Lorenza Jachia Secretary, Working Party on Regulatory Cooperation and Standardization Policies, UN Economic Commission for Europe

The UNECE Sectoral Initiative on Environments Equipment for Explosive A global legislative framework for Explosion Protection The comprehensive approach of the UNECE Model L Regulation Lorenza Jachia Secretary, Working Party on Regulatory Cooperation and Standardization Policies, UN Economic Commission for Europe

The UNECE Sectoral Initiative on Equipment for Explosive Environments A global legislative framework for Explosion Protection The comprehensive approach of the UNECE Model L Regulation

Why is the UN here? The UN aims at protecting the safety of workers, citizens, consumers: Repeated testing means that safe and reliable equipment is unaffordable for countries that need it the most The UN promotes the participation of developing countries and countries in transition in international trade: Barriers to trade are lost opportunities for our membership

1. Introduction UNECE: A bit of history Created in 1947 Original mission: To assist in the reconstruction and economic development of post war Europe UNECE was an important bridge between the two sides of the Iron Curtain: this is why many technical issues are discussed here Since the end of the cold war: integration of the newly formed Central and Eastern European countries into the world economy Many UNECE deliverables are developed by top worldwide experts and have global relevance

2. Introduction UNECE Work Areas Transport Economic cooperation Housing Statistics Trade Sustainable energy Environmental policy Forests & timber

3. Introduction UNECE Working Party on Regulatory Cooperation and Standardization Policies (WP. 6) What we are: Intergovernmental body Participation by: authorities, regional & int l organizations, business, standards-setting bodies, certification bodies, test houses, civil society 1970 2017: 46+ years Our mandate: Forum for dialogue on: Standardization Technical regulations Conformity assessment Accreditation Metrology Market surveillance Our activities: Share info & best practice Capacity-building Develop and maintain a set of recommendations Implement a set of initiatives on specific industrial sectors

4. Introduction WP. 6 Main areas of work Sectoral initiatives: Develop a common regulatory framework in specific sectors So far: Telecommunications, Earth-moving equipment, ExEquipment, Pipeline Safety Market surveillance: Develop and share best practice/recommendations New recommendation S on Applying Predictive Risk Management Tools for Targeted Market Surveillance Develop a common terminology Advisory services/technical assistance Worldwide database of market surveillance authorities Risk Management: Best practice/recommendation on using risk management tools in developing and implementing regulations 2 Recommendations on Crisis Management and Risk management in Regulatory systems Book on Risk Management in Regulatory Systems

1. Introduction

WP.6 works towards better and convergent regulations In sectors of high concern Governments define common regulatory arrangements i.e. they define legitimate government concerns (public health, safety, protection of the environment, interoperability, etc) And agree on how to reach them By reference to international standards Specifying: how compliance is assessed which conformity assessment bodies are recognized as competent, what competence criteria are to be fulfilled

Recommendations Seventeen UNECE recommendations have been adopted by the Working Party since 1970 to address standardization and regulatory issues. They set out good practice regarding: Regulatory cooperation Metrology Standards and Norms Conformity assessment Market surveillance Recommendations are not binding and do not aim at rigidly aligning technical regulations across countries. Working Party encourages rule makers to base their regulations on international standards to provide a common denominator to the norms that apply in different markets.

Revised in November 2015 Recommendation L A set of tools Countries can use to harmonize their technical regulations and regulatory systems in any sector at a regional or global level It has also been used to harmonize regulations in all sectors between two countries or within a customs union Builds on the principles of the WTO TBT Agreement but goes further

In practice: Authorities decide to work together on a specific sector They agree on CRAs They transpose the CRAs into national technical regulations Then, when products have been assessed in the exporting country as compliant with the CRAs they can automatically be sold in other markets with no further assessment.

Sector Initiative on Equipment for Explosive Environments (SIEEE) Status Report: 2007: Kick off meeting in Geneva 2008: Survey on regulatory frameworks 2009: Launch of the initiative and presentation of the Common Regulatory Objectives Awareness raising workshops: 2011 Split 2012 Dubai 2013 Fortaleza 2014 Kuala Lumpur IECEx International Conferences: 2012 Dubai 2015 Gdańsk 2017 Shanghai

The workshop idea: Regulators Dialogue Group Den Haag 2014 Gdansk 2015 Fortaleza 2013 Dubai 2012 Kuala Lumpur 2014 Outputs: Comprehensive description of the methodology of the system Guidance documents for the various stakeholders (Regulators, Market Surveillance, Manufacturer, Operator, Inspection bodies)

Interest of the Industry using Ex-Products Users in the chemical and petroleum industry act more and more globally with a single engineering approach for their plants to earn savings of engineering, installation and maintenance costs to buy the equipment in a larger number and to get a better price per piece to have benefit from the global competition under manufacturers Barriers against this tendency are domestic rules and regulations which require special engineering for the plants from country to country.

Interest of the Industry manufacturing Ex- Products Manufacturers want to sell and manufacture their products without additional national differences for the product and delays to the market in accordance to one global standard (IEC / ISO) without double-testing of their product without formal restrictions to place it on the market Barriers against this tendency are domestic rules and regulations which require special differences for the product from country to country.

Principal of Ex-Business Operation Product Standardization Protection Market Surveillance Construction Fundament Manufacturer Certification Operator Regulation Knowledge, Research, Development

History/Structure National European International Regulation Up to the seventies Old New Approach Common Regulatory Arrangements (CRA)? Standardization DIN DKE CEN Cenelec ISO IEC Certification Product Product Product + Production Product + Production Installation Maintenance Repair Some basics of Ex-Equipment Levels Certification by Third Party Very High risk Zone 0 High risk Zone 1 Normal risk Zone 2 Yes Yes Yes/No

4. Summary

Intention of the Common Regulatory Arrangements (CRA) White paper approach to cover comprehensively all relevant issues in order to achieve a globally accepted safety level to provide a global Best Practice model as template for national regulation Focus to the main objectives Easy to understand Open for national modifications Specify the distributed roles and related responsibilities of the involved parties: Regulator Market Surveillance Certification Body Manufacturer End user/operator Open for ongoing maintenance and modification 2. Common Regulatory Objectives

2. Common Regulatory Arrangements Intention of the Common Regulatory Arrangements (CRA) Manufacturer Repair EN/IEC 60079-19 Operator Life cycle approach Placing on the market Market Surveillance Ex-Equipment (Installed basis) Inspection and Maintenance EN/IEC 60079-17 EN/IEC 60079-ff EN/IEC 80079-ff EN/IEC 60079-10 EN/IEC 60079-14 Installation Zone classification ( Risk Assessment ) Regulators Jurisdiction

Interaction/Relationship within the SIEEE-System Marketsurveillance Certification Bodies Regulation Operator Manufacturer 1. Definition/Jurisdiction a) Market Surveillance b) Certification Bodies c) Manufacturer d) Operator 2. Interaction a. Cert. B. Manu. b. Manu. Oper. c. MS Oper. d. MS Manu. e. MS Insp. B. f. Cert. B. Insp. B.

CRA Part 1: Requirement for the equipment Placing on the market» Elimination of possible ignition sources in accordance to intended use of the equipment, typical ignition sources are:» Hot surfaces» Electrical sparks 13 Ignition sources» Mechanical sparks» Electrostatic» Validated protection concepts ( Types of Protection ) have to be applied IEC/ISO 60079 X / 80079 X» Instructions (manual) about the intended use, installation and repair IEC/ISO 60079 X / 80079 X» Conformity assessment procedure in accordance to an international certification scheme such as IECEx (IECEx procedure can be seen as a reference) IECEx 02

CRA Part 2: Safe use of the equipment» Classification of the explosive substances in accordance to:» Ignition Temperature» Explosions Groups (Ignition Energy) Ex d e IIC T3 Gb» IEC-Zone Classification Concept (Zones for Gas and Dust) with the applicable Equipment Protection Levels IEC 60079 10» The equipment and its installation need to be inspected and maintained IEC 60079 14, 17, 19» Requirements for the competency of persons (selection, installation, use of the equipment) IECEx 05» Requirements for service facilities (e.g. repair workshops) IECEx 03» The Explosion risk assessment of an individual plant needs to be documented in the Explosion Protection Document

CRA Part 1 and 2: Certification Testing ISO/IEC 17025 IECEx 02 ISO Guide 65 / 67 [ISO/IEC 17065] IECEx 02 IEC ISO IECEx Persons Competency Production ISO/IEC 17021 Service IECEx 03 ISO/IEC 17024 IECEx 05

CRA Part 3: Standards reference list» Accepted Standards (ISO/IEC) are listed in an annex to the regulation (State of the Art)» The standards has to be accepted by a Standard Acceptance Group» After the acceptance the Standards can be applied by manufacturers and end users to show compliance with the regulation» All countries which have implemented the Regulation enjoy the advantages like barrier free trade of explosion protected equipment and equal conditions for operating a plant bearing explosion risks

CRA Part 4: Conformity assessment bodies» The accreditation body has to be a member of ILAC/IAF» The accreditation of» Conformity Assessment Bodies» Test Laboratories has to follow the applicable ISO/IEC-Standards» One member of the assessor team needs competence in the field of explosion protection (see e.g. the list of approved IECEx assessors).» Procedures and Rules of the IEC Conformity Assessment System IECEx is to take as a reference for conformity assessment

CRA Part 5: Steering Committee» An Explosion Protection Steering Committee is to formed and operated under the umbrella of UNECE WP.6 (ExSC) to monitor the application experiences» All member having implemented the CROs can participate in the Explosion Steering Committee (ExSC)» ExSC notifies the members of the Standard Acceptance Group» Observers like» Standardization Organization (IEC/ISO)» Market Surveillance» IECEx are also invited to attend the meetings

CRA Part 6: Market surveillance» A Market Surveillance network specialized in Ex-Equipment is to be formed and operated (UNECE-ExMars)» For critical non-conformance of Ex-Equipment an Alert-System is necessary Ex - Market Surveillance Concept based on the general concept of the MARS Group Strategy: Developing a general procedure for market surveillance (GMSP) Increasing cooperation with stakeholders and sharing the work of Market Surveillance internationally Increasing the visibility of Market Surveillance to the outside world

Guidelines for the Ex-Market Surveillance Contents: 1. Introduction: 2. Actions of the MS 2.1 Pro Active 2.2 Reactive 3. Cooperation and Exchange of Experience (with other stakeholder) 3.1 Internet-Platform 3.2 Arbitration Board 3.3 Alert-System 4. Definition of Ex-Products and the boundary conditions 4.1 Zone Concept (Essential Requirements) 4.2 Types of Protection (Applicable Standards) 5. Explanation of the objectives of the surveillance activities (Compliance Criteria) 5.1 Labeling and Conformity Declaration 5.2 Manual 5.3 Technical Inspection 6. List of References

United Nations Integrates 193 Nations UNECE United Nations Economic Commission for Europe One of Five Regional Commissions 56 Countries Working Party 6 One of X Working Parties SIEEE Sector Initiative Equipment Explosive Environments One of Four Initiatives Common Regulatory Arrangements

Thank you Lorenza Jachia Secretary, Working Party on Regulatory Cooperation and Standardization Policies, UN Economic Commission for Europe Lorenza.Jachia@unece.org